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Completed

NCT Number: NCT02503787

OPTIONS Spinal Cord Stimulation Programming Parameters

The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.

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Key information

Conditions

Pain, Intractable Back Pain Chronic Pain Failed Back Surgery Syndrome Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valley Pain Consultants-North Scottsdale, Scottsdale, Arizona, United States

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About this study

Prospective, multi-center, open-label study evaluating programming options in spinal cord stimulation on pain relief. All eligible subjects will undergo a Spinal Cord Stimulation (SCS) device trial that includes an intraoperative programming trial. Subjects experiencing a positive response to the programming parameters (improvement in average overall pain relief) during the trial from baseline will move forward with a permanent implant. Those not reporting a positive response to the programming parameters will be exited from the study.

The subjects will complete a number of assessment worksheets to characterize their Quality of Life and function and the level of pain they are experiencing from the baseline to 3 months post neurostimulation trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Candidate for Spinal Cord Stimulation (SCS) system (trial and implant) per labeled indication(back and leg pain)
  • Willing and able to provide a signed and dated informed consent
  • At least 18 years old at the time of informed consent
  • Willing and able to attend visits and comply with the study protocol
  • Capable of using the patient programmer and recharging the neurostimulator
  • Willing to not increase pain medications from baseline through the 3-Month Visit

Exclusion criteria

  • Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results.
  • Psychological or other health conditions that would interfere with the subject's ability to fulfill the requirements of the protocol.
  • Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
  • Implanted with a cardiac device (e.g., pacemaker, defibrillator)

Treatment and study plan

Spinal cord stimulation (SCS)

Device

SCS programming options

Primary outcomes

  1. Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire

    Time frame: From baseline to 3 months post device activation

    Self reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).

Secondary outcomes

  1. Patient Global Impression of Change

    Time frame: From baseline to 3 months post device activation

    Evaluate study subject impression of change as measured by the Patient Global Impression of Change questionnaire. The questionnaire encompasses change in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, scored on a scale of 1-7 (1=no change or the condition has gotten worse: 7=A great deal better, and a considerable improvement that has made all the difference).

Other outcomes

  1. Change in Average Back Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire

    Time frame: From baseline to 3 months post device activation

    Self reported daily average back pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).

  2. Change in Average Leg Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire

    Time frame: From baseline to 3 months post device activation

    Self reported daily average leg pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

A Prospective, Multi-center, Open-label Study of Programming Options in Spinal Cord Stimulation.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 21, 2015
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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